Isolated Cardiotomy Circuit for Re-infusion of Unwashed Shed Blood During Off-pump Coronary Artery Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood transfusion requirements
研究概览
简要总结
To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit.
详细描述
Introduction Blood transfusion is often required during cardiac surgical operations, and may be associated with known risks and complications. Off-pump coronary artery surgery has been shown to be associated with reduced need for blood transfusion, and cell-savers are widely used as an additional method for reducing blood transfusion demands.
Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications, but data related to this approach are scares.
Aims
To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique. Assessments will focus on:
- clinical outcome
- transfusion requirements
- inflammatory response
- alveolar/arterial oxygen pressure gradients
- cognitive status
- cost-benefit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to the group type when analyzing data
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing isolated off-pump coronary artery bypass surgery between March 1st, 2024 and March 31st, 2026.
排除标准
- •Missing data.
- •Patients outside the study period.
- •Patients under the age of 40 years or over the age of 75 years.
- •Patients with impaired left ventricular function (EF less the 40%).
- •Patients with history of renal failure, hepatic failure, CVA, or TIA.
- •Patients who have not stopped anticoagulants (except aspirin) for 4 days preoperatively.
- •Emergency operations.
研究组 & 干预措施
Group 2: No circuit
No re-infusion of unwashed shed blood
Group 1: Use of circuit
Re-infusion of unwashed shed blood
干预措施: Re-infusion of unwashed shed blood (Procedure)
结局指标
主要结局
blood transfusion requirements
时间窗: up to 5 days post-operatively
volume of blood (ml) transfused
inflammatory response
时间窗: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in IL-6
alveolar/arterial oxygen pressure gradients
时间窗: pre-, 4 hours post-operatively, and post-extubation
changes in alveolar/arterial oxygen pressure gradients peri-operatively
cost-benefit
时间窗: up to 5 days postoperatively
cost of blood products, circuits and hospital stay
Neuro-markers
时间窗: pre-operatively, immediately post-operatively, and 24 hours post-operatively
Changes in S-100
myocardial marker CK-MB
时间窗: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in CK-MB
complement response
时间窗: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in C3a
blood loss
时间窗: up to 24 hours post-operatively
volume (ml) of blood lost
myocardial marker troponin-I
时间窗: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in troponin-I
次要结局
未报告次要终点